As a Senior CRA you will work on the frontline of communication with project stakeholders ensuring timelines targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects rights safety and wellbeing and quality of data compliance.
OfficeBased or Homebased
You will:
- Conduct and report all types of onsite monitoring visits
- Be involved in study startup (if applicable)
- Perform CRF review source document verification and query resolution
- Be responsible for site communication and management
- Supervise study activities timelines and schedules on the country level
- Be a point of contact for inhouse support services and vendors
- Be involved in quality control such as compliance monitoring and reports review
- Participate in feasibility research
- Support regulatory team in preparing documents for study submissions
Qualifications :
- College/University degree in Life Sciences or an equivalent combination of education training & experience
- Independent onsite monitoring experience in USA (5 years minimum)
- Experience in all types of monitoring visits in Phase II and/or III
- Participation in clinical projects as a Lead/Senior Monitor
- Experience monitoring complex Oncology (breast cancer) trials required
- Full working proficiency in English
- Proficiency in MS Office applications
- Ability to plan multitask and work in a dynamic team environment
- Communication collaboration and problemsolving skills
- Ability to travel
- Valid drivers license (if applicable)
Remote Work :
Yes
Employment Type :
Fulltime